| CTRI Number |
CTRI/2018/04/012977 [Registered on: 03/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
29/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Unani Formulation in the management of Urinary Incontinence |
|
Scientific Title of Study
|
Therapeutic Evaluation of Unani Formulation in Stress Urinary Incontinence (Salisululbol): A Randomized Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JUVERIYA NAAZ N BHUSNUR |
| Designation |
PG Scholar |
| Affiliation |
Luqman Unani Medical College, Hospital and Research Centre |
| Address |
Department of Ilmul Qabalat Wa Amraze Niswan,
Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Bijapur 586101
Bijapur
KARNATAKA
586101
India |
| Phone |
9739814729 |
| Fax |
|
| Email |
drjuveriya10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mariyam Roqaiya |
| Designation |
Lecturer, |
| Affiliation |
Luqman Unani Medical College, Hospital and Research Centre |
| Address |
Department of Ilmul Qabalat Wa Amraze Niswan,
Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Bijapur
Bijapur
KARNATAKA
586101
India |
| Phone |
9632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariyam Roqaiya |
| Designation |
Lecturer |
| Affiliation |
Luqman Unani Medical College, Hospital and Research Centre |
| Address |
Department of Ilmul Qabalat Wa Amraze Niswan,
Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Bijapur
Bangalore Rural
KARNATAKA
586101
India |
| Phone |
9632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman Unani Pharmacy
Luqman Unani Medical College, Hospital and Research Centre,
12-naubag Bijapur Karnataka-586101 |
|
|
Primary Sponsor
|
| Name |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Department of Ilmul Qabalat Wa Amraze Niswan,
Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Bijapur 586101
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mariyam Roqaiya |
Luqman Unani Medical College Hospital and Research Centre |
Department of Ilmul Qabala Wa Amraz Niswan
Luqman Unani Medical College Hospital and Research Centre 12 Naubag Bijapur karnataka
Bijapur
KARNATAKA |
9739814729
drjuveriya10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
stress Urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Roasted Wheat Flour
in the Capsule form
thrice a Day for 60 days |
| Intervention |
Unani formulatio |
Mur (Commiphora myrrha)
Balut (Quercus incana)
Saadkofi (Cyperus scariosus)
Kundur (Boswalia serrata)
in the capsulee form thrice a day for 60 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients of SUI clinically assessed will be included in the study after obtaining their voluntary consent |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Women on OCPs
Patients with 3rd and 4th degree genital prolapse
history of systemic illnesses, endocrinal diseases and malignancies
history ofany pharmacological intervention within 3 months and have had surgical intervention for SUI.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the number of incontinent episode assessed by bladder diary.
Reduction in ICIQ-SF score.
|
60days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pelvic floor muscle strength assessed by Modified Oxford Grading Scale.
Stress test
|
60days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/03/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
0 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients meeting all the inclusion criteria will be randomly allocated either to test (n=20) or control group (n=20) after taking their consent. Patients will be blinded for the study. In test group polyherbal unani formulation will be given for 60 days and in the control group placebo will be given for the same duration. Kiegel’s exrecise will be advised to both the groups. Subjective parameters will be assessed on each visit and objective parameters will be assessed before and after treatment. |